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Validation of software of machines and equipment related to production process

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Guest user Created:   Oct 02, 2020 Last commented:   Oct 05, 2020

Validation of software of machines and equipment related to production process

Need to validate the software of machines and equipment related to the production process and not to the product.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 05, 2020

Yes, you need to validate software of machine and equipment related to the production process, but only when there is a new revision of the software; when you get information from the machine manufacturer that there is a necessity to update the software. 

If that is not the case, then you do not need to regularly validate that software.  

You can see how records of software validation look in ISO 13485:2016 Documentation toolkit on the following link:

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Oct 02, 2020

Oct 05, 2020